Study of Vinorelbine Liposomes Injection for Advanced Solid Tumors, Non-Hodgkin's Lymphoma or Hodgkin's Disease

Phase 1

Completed

• Conditions: Tumors; Hodgkins Disease; Non-Hodgkins Lymphoma
• Interventions: Drug: VLI

• Registration Number: NCT00364676
• Lead Sponsor: Spectrum Pharmaceuticals, Inc

Brief Summary

This Phase 1 study will determine the safety, tolerability, and pharmacokinetics of vinorelbine liposomes injection (VLI) in patients with advanced solid tumors, non-Hodgkin's lymphoma, or Hodgkin's disease.

Detailed Description

The objectives of this study are:

* To assess the safety and tolerability of treatment with VLI.

* To determine the maximum tolerated dose (MTD) of VLI.

* To characterize the pharmacokinetic (PK) profile of VLI.

* To explore preliminary tumor response of VLI.

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-08-14
• Study First Submitted QC: 2006-08-14
• Study First Posted: 2006-08-16
• Primary Completion: 2015-06
• Study Completion: 2015-08
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-18
• Last Update Posted: 2015-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

1. Histologically confirmed solid tumor refractory to standard therapy or for which no standard therapy is known to exist, or relapsed and/or refractory non-Hodgkin's lymphoma or Hodgkin's disease
2. Adequate hematologic, hepatic and renal functions as defined by laboratory tests.
3. At least 18 years of age.
4. Have a life expectancy of at least 12 weeks.
5. Patients must give written informed consent.
6. ECOG or Zubrod performance status of 0, 1, or 2.

Exclusion Criteria

1. Primary tumors of central nervous system (CNS). Symptomatic brain metastases (unless patient is stable without requirement of steroids and/or antiseizure medications for at least 3 months) or leptomeningeal tumor involvement.
2. Prior chemotherapy or radiotherapy within 4 weeks prior to study entry (6 weeks for nitrosoureas and mitomycin C).
3. Planned concurrent systemic therapy and/or radiotherapy drug study treatment.
4. Use of investigational drugs, biologics or devices within 28 days prior to study treatment or planned use during the course of the study.
5. Active infection or any serious underlying medical condition, which would impair the ability of the patient to receive protocol treatment.
6. Prophylactic hematologic growth factors administered less than or equal to 2 weeks prior to start of therapy with VLI (excluding darbepoetin alfa, epoetin alfa).
7. Female patients who are pregnant or lactating.
8. Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	VLI	Patients are dosed on Day 1 and Day 8 of a 21-day cycle.
2	VLI	Patients are dosed on Day 1 of a 21-day cycle.

Primary Outcome Measures

Name	Time	Method
Evaluate the safety and tolerability of VLI.	21 Days

Secondary Outcome Measures

Name	Time	Method
To determine the maximum tolerated dose (MTD)	21 Days

Trial Locations

Locations (3)

Cancer Therapy and Research Center; 🇺🇸 San Antonio, Texas, United States

McGill Centre for Translational Research in Cancer-Jewish General Hospital Clinical Research Unit; 🇨🇦 Montreal, Quebec, Canada

South Texas Accelerated Research Therapeutics; 🇺🇸 San Antonio, Texas, United States